Detailed SMPC and OD register data for: Nexviadyme 100 mg powder for concentrate for solution for infusion
Data as extracted from Orphan Designation Register
Product (OD)
Nexviadyme 100 mg powder for concentrate for solution for infusion
PL number (OD)
PLGB 04425/0893
OD Designation ID (OD)
OD1
Active substance (OD)
AVALGLUCOSIDASE ALFA
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.
SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
Higher confidence means the match is more likely to be correct.
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid ?-glucosidase deficiency)
Full Designation Number(OD)
PLGB 04425/0893/OD1
Orphan Condition(OD)
Glycogen storage disease type II (Pompe’s disease)
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL